Manufacturers of consumer goods, specifically, manufacturers of food products annually devote a substantial amount of time, effort and resources to improving the products they offer. These improvements can take the form of improved taste or texture, reduced calories or fat content and the like. More recently, and as the population matures, food companies are looking more and more into food products, food components or ingredients that deliver a particular health or nutritional benefit. That is, food products that may assist the consumer in living a healthier life in that the food product aids in reducing high cholesterol levels, mitigating the risk of heart diseases, diminishing the risk of some cancers and many other illnesses and diseases, which become more prevalent as society ages or dietary patterns are modified to meet the changing lifestyles of today's population.
One health claim that has received a lot of interest lately is the effect of using sterols/stanol, steryl esters and other fatty acid derivatives and combinations thereof to reduce unhealthy or high cholesterol levels. In this regard, a number of internationally known food manufacturers have successfully manufactured and marketed starch-containing food products that have certain levels of sterols and steryl esters in order to deliver a product that provides this health benefit. Such starch-containing food products include ready to eat (RTE) cereals, dough based products, RTE meals and the like.
It is well known that cholesterol in humans comes from primarily two sources, the body's own production of cholesterol (endogenous) and dietary cholesterol (exogenous). Typically, the average person consumes between 350-400 milligrams of cholesterol daily, while the recommended intake is around 300 milligrams. Increased dietary cholesterol consumption, especially in conjunction with a diet high in saturated fat intake, can result in elevated serum cholesterol. Elevated serum cholesterol is a well-established risk factor for heart disease and therefore there is a need to mitigate the undesired effects of cholesterol accumulation. High cholesterol levels are generally considered to be those total cholesterol levels at 200 milligrams per deciliter and above or LDL cholesterol levels at 130 milligrams per deciliter and above.
Lipoproteins contain specific proteins and varying amounts of cholesterol, triglycerides and phospholipids. There are three major classes of lipoproteins and they include very low density lipoproteins (“VLDL”), low density lipoproteins (“LDL”) and high density lipoproteins (“HDL”). The LDLs are believed to carry about 60-70% of the serum cholesterol present in an average adult. The HDLs carry around 20-30% of serum cholesterol with the VLDL having around 1-10% of the cholesterol in the serum. To calculate the level of non-HDL cholesterol present (find the level of LDL or VLDL levels), which indicates risk, the HDL is subtracted from the total cholesterol value. By lowering the total system LDL cholesterol level, it is believed that certain health risks, such as coronary disease and possibly some cancers, that are typically associated with high cholesterol levels, can be reduced.
Numerous studies relating to modifying the intestinal metabolism of lipids have been done to illustrate that such effects can reduce a high cholesterol level. This may be done by hampering the absorption of triglycerides, cholesterol or bile acids. It is believed that certain plant sterols, steryl esters, stanols fatty acid derivatives and combinations thereof lower serum cholesterol levels by reducing the absorption of dietary cholesterol and/or bile acids from the intestines.
Sterols occur in natural fats and oils, particularly in vegetable oils. Unsaturated vegetable oils and non-animal fat oils, such as soybean oil, wheat germ oil, cottonseed oil, safflower oil, peanut oil, rice oil, canola oil and the like are well known sources of β-sitosterol, stigmasterol, ergosterol and campesterol as well as various other materials such as higher aliphatic alcohols. Tall oil is also a significant source of β-sitosterol and campesterol.
Stanols (β-sitostanol, campestanol, stigmastanol and fatty acid derivatives thereof) are the 5 alpha saturated derivatives of plant sterols and may be derived from similar sources set forth above.
Natural plant sterols are similar structurally to cholesterol except in the arrangement of the basic side chains. Absorption of plant sterols in the intestines is believed to be minimal at best and sterols/steroids are generally excreted in the stool. Thus, the levels of plant sterols in the serum are relatively low since they are not absorbed by the body and are relatively quickly excreted. Where the amount of sterols is increased in an effort to obtain greater beneficial or health effects, the sterols still do not increase significantly in amount in the blood serum as the absorption capability, however limited it may be, is quickly exceeded. Hence, the interest in including sterol related or containing compounds in food products, food ingredients and food components (the presumed health benefit stated above) is directly related to the manufacturer's interest in sterol inclusion into such products.
In manufacturing products that contain certain health claims, such as a RTE cereal, i.e. TOTAL® or CHEERIOS® available from General Mills, Inc. of Minneapolis, Minn., it is important that the product not only be able to support or substantiate the health claim for regulatory reasons but also that the product must actually contain the amount of the effective ingredient stated in the nutritional information provided with the package. One of the problems associated with making foods having sterol related or containing compounds is determining or verifying the actual level of sterol related or containing compounds in the end product to be consumed.
Thus, there is a need for food manufacturers to be able to accurately calculate or quantify the amount of the sterols and steryl esters in a food product so that the proper amount is delivered in each of the suggested serving or portion sizes in order that the claims of the food product are supported by the contents.
Heretofore, a number of methods using a variety of internal standards have been developed to attempt to calculate the amount of sterol related or containing compounds in the food product. However, these methods while possibly being relatively quick and inexpensive to use can in fact be detrimental to both the manufacturer from both a cost and a regulatory standpoint as well as the consumer of the product from a health related aspect.
With respect to prior methodologies employed by the food product manufacturer, readings related to determining the level of sterol based or containing compounds provided by these methods often resulted in a reading that was substantially lower than the actual amount of sterols or steryl esters that may have been added to the food products during the manufacturing process, that is, that amount added to provide or obtain the health or nutritional benefit. Often, it was found that readouts from these prior test methods would be from twenty-five to fifty percent (25-50%) lower than the actual amount of the ingredient or component that was added. Such readings would then result in the manufacturer adding even more of the ingredient or component to insure that the food product would be supported by the claims and nutritional information provided with the package, that is in the present example, to insure that enough of the sterol based compound is present. While this is a simple solution, it has significant economic disadvantages in that sterol related compounds are relatively expensive ingredients when compared on a relative weight basis with other ingredients present in the product, i.e. the grain (wheat, oat, barley), sugar, macro and micro nutrients, etc. There are also other significant disadvantages to having excessive amounts of sterol containing compounds in the food products. As used herein, the term “food products” includes food components (such as dough, flakes), food intermediates (a transitional step used in making a product or component) and a food ingredient. Where the term “food product” is used in connection with a manufacturer or manufacturing, the term is intended to imply an entity, which makes, fabricates, processes or produces food products as defined above.
It is important to insure that the right amount of the ingredient is available in each serving or portion size, not only from a manufacturing but also a regulatory standpoint. From a manufacturing point of view, cost of manufacture is a significant factor in determining profit levels. However, from a regulatory standpoint, providing an amount of sterols and steryl esters beyond an acceptable threshold can be detrimental to the health of the consumer. As such, there is a maximum amount of the ingredient that cannot be exceeded in order to qualify for the generally recognized as safe (“GRAS”) status of such sterol related compounds. As used herein, the term sterol related or containing compound refers to such compounds as β-sitosterol, stigmasterol, ergosterol, campesterol, stanols β-sitostanol, campestanol, stigmastanol and fatty acid derivatives thereof.
It is believed that the prior testing methods, which used an internal standard of cholestane, produced unacceptable results in part due to the fact that cholestane did not sufficiently chemically simulate the compounds that were being assayed to compensate for degradation or matrix binding. The problem of getting an accurate reading using current methods is that the steryl esters and sterols are bound by the starch (most probably amylopectin) during the cooking process, which is inherent in most food product manufacturing steps. Using such internal standards prior test methods were ineffectual in releasing the starch bound sterols and steryl esters resulting in readings being off by as much as fifty percent (50%) from the known amount of ingredient or component that was added to the food product or food component initially.
What is needed therefore is an accurate method for determining or quantifying the level of the sterol related or containing compounds in a particular starch containing or consumer food product or component which has a health claim or benefit associated with it so as to insure compliance with self-affirmed GRAS status as well as to maintain manufacturing economies in scale with target projections.